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Войти в исследования JACC. Cardiovascular interventions · 2025
Transcatheter Pulmonary Valve Implantation Using Self-Expandable Percutaneous Pulmonary Valve System: 3-Year CE Study Results.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Qureshi Shakeel A, Jones Matthew I, Pushparajah Kuberan, Wang Jou-Kou, Kenny Damien, Walsh Kevin, Boudjemline Younes, Promphan Worakan, Prachasilchai Pimpak, Thomson John, Bentham James R, Berger Felix, Pedra Carlos A C, Gewillig Marc, Yan Bryan P, Hijazi Ziyad M
Аннотация
BACKGROUND: Pulmonary regurgitation is common during follow-up of patients after surgical repair of tetralogy of Fallot and other right ventricular outflow tracts (RVOTs). Many percutaneous pulmonary valves have been used but are limited to smaller RVOTs.
OBJECTIVES: Since August 2016, a multicenter CE (Conformité Européenne) study was initiated to evaluate a self-expandable VenusP-valve. We aimed to report the acute and 3-year follow-up results.
METHODS: A total of 81 patients with pulmonary regurgitation were recruited for VenusP-valve implantation and assessed for a 3-year period.
RESULTS: In all patients, VenusP-valves were successfully implanted. The mean age was 26.5 ± 13.3 years and the mean weight 59.5 ± 15.6 kg. There was no early procedure-related or late mortality. One patient experienced guidewire perforation of a branch pulmonary artery, causing hemoptysis, and 1 had ventricular tachycardia, at the end of the procedure. During follow-up, 1 patient developed runs of ventricular tachycardia and needed an implantable cardioverter-defibrillator and ablation of the RVOT 5 months after valve implantation. One developed endocarditis 11 months after implantation. After medical treatment, the valve has continued to function normally. One patient developed thrombus on the distal flare 3 years after implantation and was treated with anticoagulants. During 3-year follow-up, valve function has remained satisfactory and right ventricular remodeling has occurred in all patients.
CONCLUSIONS: We report the 3-year CE study results of percutaneous pulmonary valve implantation in patients with severe pulmonary regurgitation. The valve has shown promising safety and durability. Long-term evaluation is warranted.
OBJECTIVES: Since August 2016, a multicenter CE (Conformité Européenne) study was initiated to evaluate a self-expandable VenusP-valve. We aimed to report the acute and 3-year follow-up results.
METHODS: A total of 81 patients with pulmonary regurgitation were recruited for VenusP-valve implantation and assessed for a 3-year period.
RESULTS: In all patients, VenusP-valves were successfully implanted. The mean age was 26.5 ± 13.3 years and the mean weight 59.5 ± 15.6 kg. There was no early procedure-related or late mortality. One patient experienced guidewire perforation of a branch pulmonary artery, causing hemoptysis, and 1 had ventricular tachycardia, at the end of the procedure. During follow-up, 1 patient developed runs of ventricular tachycardia and needed an implantable cardioverter-defibrillator and ablation of the RVOT 5 months after valve implantation. One developed endocarditis 11 months after implantation. After medical treatment, the valve has continued to function normally. One patient developed thrombus on the distal flare 3 years after implantation and was treated with anticoagulants. During 3-year follow-up, valve function has remained satisfactory and right ventricular remodeling has occurred in all patients.
CONCLUSIONS: We report the 3-year CE study results of percutaneous pulmonary valve implantation in patients with severe pulmonary regurgitation. The valve has shown promising safety and durability. Long-term evaluation is warranted.